MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT; STENT, ILIAC VEIN

Model Number G57453

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2023

Event Type  malfunction  

Event Description

As initially reported to customer relations: a patient of unspecified gender and age underwent an unspecified procedure previously in which the zilver vena venous self-expanding stent, g57453, was used.On april (b)(6)2023 it was noted that the stent had migrated into the patient's heart.The patient is doing okay.(pr (b)(6).Updated information: noted during other procedure, ultrasound done at 1 month and 6 months and these images can be shared.As per pr (b)(6) a 9fr sheath was used.As per ifu0091, an access sheath that accepts a 7fr introducer catheter is recommended.Patient outcome: no adverse events reported as a result of this occurrence patient/event info - notes: prefix zvt7 3.91 are images of the device or procedure available? yes 3.92 did the patient have pre-existing conditions? yes if yes, please specify: history of htn, afib, varicose veins, may-thurner, anxiety 3.93 please describe the native state of the vessel (i.E.Was the anatomy tortuous? not tortuous was the vessel fibrotic?) no if other, please specify: 3.94 was a stent previously placed during previous procedures? no 3.95 was the device used percutaneously? yes 3.96 where on the patient was the percutaneous access site? left femoral vein 3.97 was the access site jugular or femoral? n/a, jugular, femoral other if other, please specify: left femoral vein 3.98 what disease pathology was being treated? may thurner if other, please specify 3.99 was the lesion approached via contralateral or ipsilateral? ipsilateral 3.100 was pre-dilation performed ahead of placement of the stent? yes predilated with 14 balloon 3.101 what was the target location for the stent? left common iliac vein 3.102 details of access sheath used (name, fr size, length)? 9fr x 11cm super sheath 3.103 was the device flushed through both flushing ports before the procedure, as per ifu? yes 3.104 details of the wire guide used (name, diameter, hyrdophyllic)? emerald j wire, 035x150cm 3.105 was resistance encountered when advancing the wire guide to the target location? no 3.106 was resistance encountered when advancing the delivery system to the target location? no 3.107 if resistance was met, how did the physician address this? n/a 3.108 did the tip of the delivery system cross the target location? yes 3.109 did the user pull the handle towards the hub during deployment, per ifu? yes 3.110 did the user push the hub during deployment? no 3.111 did the user remove slack in the delivery system before deployment, per ifu? yes 3.112 was the stent deployed smoothly / without resistance? yes 3.113 was the stent fully deployed in the patient? yes 3.114 was the stent fully deployed before removing the delivery system from the patient? yes 3.115 was post dilation performed after the placement of the stent? no; evaluated under ivus with good wall apposition 3.116 was the delivery system damaged/kinked/twisted during deployment? no 3.117 what intervention (if any) was required? none 3.118 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? another day 3.119 were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a please specify if yes.

Manufacturer Narrative

Pma/510(k) # p200023.Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k)#: p200023.This file is related to (b)(4)(emdr 3001845648-2023-00382) "migrated into patients heart." device evaluation: user/use related complaints is considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required the zvt7-35-120-16-60 device of lot number: c1824523 involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.An nc code (gen-111) was noted on the work order, however this unit was subsequently scrapped and would not have attributed to this complaint issue.Review historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use/label: it should be noted that the instructions for use (ifu0091) states the following: ¿gain access at the appropriate site utilizing a 2.3mm (7.0 french) introducer sheath¿.There is evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause of the user not reading or following the instructions for use has been determined.From the additional questions it is known that an 9fr access sheath was used with the device.As previously noted, the ifu states ¿gain access at the appropriate site utilizing a 2.3mm (7.0 french) introducer sheath¿.Confirmation of complaint: the complaint is confirmed based on customer and/or rep testimony.Summary: according to the additional information received, it is known that an 9fr access sheath was used with the device.The ifu instructs to use a 7fr access sheath.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the patient did not experience any adverse effects as a result of this occurrence.Investigation findings conclude a definitive root cause of use error was established.The user has not complied with the requirements of the ifu.From the information available, it is known that an 9fr access sheath was used with the device and not the intended 7fr size as required as per the ifu.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 09-oct-2023.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Type of Device: STENT, ILIAC VEIN
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 17037198
• MDR Text Key: 317641779
• Report Number: 3001845648-2023-00425
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574530
• UDI-Public: (01)10827002574530(17)240428(10)C1824523
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: G57453
• Device Catalogue Number: ZVT7-35-120-16-60
• Device Lot Number: C1824523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/24/2023
• Event Location: Hospital
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 34 KG